Pharmacotherapy for obesity: recent evolution and implications for cardiovascular risk reduction

References

• Centers for Disease Control and Prevention. Adult obesity facts [Internet]. Atlanta (GA): Centers for Disease Control and Prevention, U.S. Department of Health and Human Services; 2022 May 17. [Cited 2022 Dec 10]. Available from: https://www.cdc.gov/obesity/data/adult.html
   Google Scholar
• Bray GA, Heisel WE, Afshin A, et al. The science of obesity management: an endocrine society scientific statement. Endocr Rev. 2018;39(2):79–132. DOI:10.1210/er.2017-00253
   PubMed Web of Science ®Google Scholar
• Gottfredson DC, Cook TD, Gardner FE, et al. Standards of evidence for efficacy, effectiveness, and scale-up research in prevention science: next generation. Prev Sci. 2015;16(7):893–926. DOI:10.1007/s11121-015-0555-x
   PubMed Web of Science ®Google Scholar
• Johnston BC, Kanters S, Bandayrel K, et al. Comparison of weight loss among named diet programs in overweight and obese adults: a meta-analysis. JAMA. 2014;312(9):923–933. DOI:10.1001/jama.2014.10397
   PubMed Web of Science ®Google Scholar
• Ge L, Sadeghirad B, Ball GDC, et al. Comparison of dietary macronutrient patterns of 14 popular named dietary programmes for weight and cardiovascular risk factor reduction in adults: systematic review and network meta-analysis of randomised trials. BMJ. 2020;369:m696.
   PubMedGoogle Scholar
• Schwingshackl L, Zähringer J, Nitschke K, et al. Impact of intermittent energy restriction on anthropometric outcomes and intermediate disease markers in patients with overweight and obesity: systematic review and meta-analyses. Crit Rev Food Sci Nutr. 2021;61(8):1293–1304.
   PubMed Web of Science ®Google Scholar
• Anton SD, Hida A, Heekin K, et al. Effects of popular diets without specific calorie targets on weight loss outcomes: systematic review of findings from clinical trials. Nutrients. 2017;9(8):822. DOI:10.3390/nu9080822
   PubMed Web of Science ®Google Scholar
• Knowler WC, Barrett-Connor E, Fowler SE, et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002;346(6):393–403.
   PubMed Web of Science ®Google Scholar
• Wing RR, Bolin P, Brancati FL, et al. Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes. N Engl J Med. 2013;369(2):145–154. Erratum in: N Engl J Med. 2014;370(19):1866.
   PubMed Web of Science ®Google Scholar
• Schwingshackl L, Dias S, Hoffmann G. Impact of long-term lifestyle programmes on weight loss and cardiovascular risk factors in overweight/obese participants: a systematic review and network meta-analysis. Syst Rev. 2014;3(1):130. DOI:10.1186/2046-4053-3-130
   PubMedGoogle Scholar
• LeBlanc ES, Patnode CD, Webber EM, et al. Behavioral and pharmacotherapy weight loss interventions to prevent obesity-related morbidity and mortality in adults: updated evidence report and systematic review for the US preventive services task force. JAMA. 2018;320(11):1172–1191. DOI:10.1001/jama.2018.7777
   PubMed Web of Science ®Google Scholar
• Madigan CD, Graham HE, Sturgiss E, et al. Effectiveness of weight management interventions for adults delivered in primary care: systematic review and meta-analysis of randomised controlled trials. BMJ. 2022;377:e069719. DOI:10.1136/bmj-2021-069719
   PubMedGoogle Scholar
• Khera R, Murad MH, Chandar AK, et al. Association of pharmacological treatments for obesity with weight loss and adverse events: a systematic review and meta-analysis. JAMA. 2016;315(22):2424–2434. DOI:10.1001/jama.2016.7602
   PubMed Web of Science ®Google Scholar
• Sisti LG, Dajko M, Campanella P, et al. The effect of multifactorial lifestyle interventions on cardiovascular risk factors: a systematic review and meta-analysis of trials conducted in the general population and high risk groups. Prev Med. 2018 Apr;109:82–97.
   PubMed Web of Science ®Google Scholar
• Garvey WT, Mechanick JI, Brett EM, et al. American Association of Clinical Endocrinologists and American College of Endocrinology Comprehensive Clinical Practice Guidelines for Medical Care of Patients with Obesity. Endocr Pract. 2016;22(Suppl 3):1–203. DOI:10.4158/EP161365.GL
   PubMed Web of Science ®Google Scholar
• Jensen MD, Ryan DH, Apovian CM, et al. AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Obesity Society. Circulation. 2014;129(25 Suppl 2):S102–38. DOI:10.1161/01.cir.0000437739.71477.ee
   PubMed Web of Science ®Google Scholar
• Pi-Sunyer X. The Look AHEAD Trial: a review and discussion of its outcomes. Curr Nutr Rep. 2014;3(4):387–391.
   PubMedGoogle Scholar
• Adams TD, Davidson LE, Litwin SE, et al. Weight and metabolic outcomes 12 years after gastric bypass. N Engl J Med. 2017;377(12):1143–1155. DOI:10.1056/NEJMoa1700459
   PubMed Web of Science ®Google Scholar
• Peterli R, Wölnerhanssen BK, Peters T, et al. Effect of laparoscopic sleeve gastrectomy vs laparoscopic Roux-en-Y gastric bypass on weight loss in patients with morbid obesity: the SM-BOSS randomized clinical trial. JAMA. 2018;319(3):255–265. DOI:10.1001/jama.2017.20897
   PubMed Web of Science ®Google Scholar
• Salminen P, Grönroos S, Helmiö M, et al. Effect of laparoscopic sleeve gastrectomy vs Roux-en-Y gastric bypass on weight loss, comorbidities, and reflux at 10 years in adult patients with obesity: the SLEEVEPASS randomized clinical trial. JAMA Surg. 2022;157(8):656–666.
   PubMed Web of Science ®Google Scholar
• Sjöström L. Review of the key results from the Swedish obese subjects (SOS) trial - a prospective controlled intervention study of bariatric surgery. J Intern Med. 2013 Mar;273(3):219–234.
   PubMed Web of Science ®Google Scholar
• Bailly L, Schiavo L, Sebastianelli L, et al. Preventive effect of bariatric surgery on type 2 diabetes onset in morbidly obese inpatients: a national French survey between 2008 and 2016 on 328,509 morbidly obese patients. Surg Obes Relat Dis. 2019;15(3):478–487. DOI:10.1016/j.soard.2018.12.028
   PubMed Web of Science ®Google Scholar
• Schauer PR, Bhatt DL, Kirwan JP, et al. Bariatric surgery versus intensive medical therapy for diabetes - 5-year outcomes. N Engl J Med. 2017;376(7):641–651. DOI:10.1056/NEJMoa1600869
   PubMed Web of Science ®Google Scholar
• Mentias A, Aminian A, Youssef D, et al. Long-term cardiovascular outcomes after bariatric surgery in the Medicare population. J Am Coll Cardiol. 2022;79(15):1429–1437. DOI:10.1016/j.jacc.2022.01.047
   PubMed Web of Science ®Google Scholar
• Adams TD, Meeks H, Fraser A, et al. Long-term all-cause and cause-specific mortality for four bariatric surgery procedures. Obesity (Silver Spring). 2023 Feb;31(2):574–585.
   PubMed Web of Science ®Google Scholar
• van Veldhuisen SL, Gorter TM, van Woerden G, et al. Bariatric surgery and cardiovascular disease: a systematic review and meta-analysis. Eur Heart J. 2022;43(20):1955–1969. DOI:10.1093/eurheartj/ehac071
   PubMed Web of Science ®Google Scholar
• Wiggins T, Guidozzi N, Welbourn R, et al. Association of bariatric surgery with all-cause mortality and incidence of obesity-related disease at a population level: a systematic review and meta-analysis. PLOS Med. 2020 Jul 28;17(7):e1003206.
   PubMed Web of Science ®Google Scholar
• U.S. Government Accountability Office. Obesity drugs: few adults used prescription drugs for weight loss and insurance coverage varied GAO-19-577; 2019 Aug [Cited 2022 Dec 11]. Available from: https://www.gao.gov/products/GAO-19-577
   Google Scholar
• Gadde KM, Atkins KD. The limits and challenges of antiobesity pharmacotherapy. Expert Opin Pharmacother. 2020;21(11):1319–1328.
   PubMed Web of Science ®Google Scholar
• Gardin JM, Schumacher D, Constantine G, et al. Valvular abnormalities and cardiovascular status following exposure to dexfenfluramine or phentermine/fenfluramine. JAMA. 2000;283(13):1703–1709. DOI:10.1001/jama.283.13.1703
   PubMed Web of Science ®Google Scholar
• Capristo E, Maione A, Lucisano G, et al. Effects of weight loss medications on mortality and cardiovascular events: a systematic review of randomized controlled trials in adults with overweight and obesity. Nutr Metab Cardiovasc Dis. 2021;31(9):2587–2595. DOI:10.1016/j.numecd.2021.05.023
   PubMed Web of Science ®Google Scholar
• U.S. Food and Drug Administration. FDA requests the withdrawal of the weight-loss drug belviq, belviq XR (lorcaserin) from the market. Potential risk of cancer outweighs the benefits [Internet]. Silver Spring (MD): U.S. Food and Drug Administration, U.S. Department of Health and Human Services; 2020 Feb 13; [Cited 2023 Jan 4]. Available from: https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-withdrawal-weight-loss-drug-belviq-belviq-xr-lorcaserin-market
   Google Scholar
• U.S. Food and Drug Administration. FDA drug safety communication: FDA recommends against the continued use of Meridia (sibutramine) [Internet]. Silver Spring (MD): U.S. Food and Drug Administration, U.S. Department of Health and Human Services; 2010 Oct 8; [Cited 2023 Jan 4]. Available from: https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-recommends-against-continued-use-meridia-sibutramine
   Google Scholar
• Sam AH, Salem V, Ghatei MA. Rimonabant: from RIO to ban. J Obes. 2011;2011:432607.
   PubMedGoogle Scholar
• ADIPEX-P® (phentermine hydrochloride) [package insert]. Parsippany (NJ): Teva Pharmaceuticals USA; 2020. Available from: https://www.adipex.com/globalassets/adipex/adipex_pi.pdf
   Google Scholar
• Aronne LJ, Wadden TA, Peterson C, et al. Evaluation of phentermine and topiramate versus phentermine/topiramate extended-release in obese adults. Obesity (Silver Spring). 2013;21(11):2163–2171. DOI:10.1002/oby.20584
   PubMed Web of Science ®Google Scholar
• XENICAL® (orlistat) [package insert]. Montgomery (AL): H2-Pharma, LLC; 2017. Available from: https://xenical.com/pdf/PI_Xenical-brand_FINAL.PDF
   Google Scholar
• QSYMIA® (phentermine and topiramate) [package insert]. Campbell (CA): VIVUS, LLC; 2022. Available from: https://qsymia.com/patient/include/media/pdf/prescribing-information.pdf?v=0422
   Google Scholar
• CONTRAVE® (naltrexone hydrochloride and bupropion hydrochloride) [package insert]. Brentwood (TN): Nalpropion Pharmaceuticals, LLC; 2021. Available from: https://www.contravehcp.com/wp-content/uploads/Contrave_PI.pdf
   Google Scholar
• SAXENDA® (liraglutide) [package insert]. Plainsboro (NJ): Novo Nordisk, Inc.; 2022. Available from: https://www.novo-pi.com/saxenda.pdf
   Google Scholar
• WEGOVY® (semaglutide) [package insert]. Plainsboro (NJ): Novo Nordisk, Inc.; 2022. Available from: https://www.novo-pi.com/wegovy.pdf
   Google Scholar
• Min T, Bain SC. The role of tirzepatide, dual GIP and GLP-1 receptor agonist, in the management of type 2 diabetes: the SURPASS clinical trials. Diabetes Ther. 2021 Jan;12(1):143–157.
   PubMed Web of Science ®Google Scholar
• Jastreboff AM, Aronne LJ, Ahmad NN, et al. Tirzepatide once weekly for the treatment of obesity. N Engl J Med. 2022;387(3):205–216. DOI:10.1056/NEJMoa2206038
   PubMed Web of Science ®Google Scholar
• Wilding JPH, Batterham RL, Calanna S, et al. Once-weekly semaglutide in adults with overweight or obesity. N Engl J Med. 2021;384(11):989–1002.
   PubMed Web of Science ®Google Scholar
• Mannucci E, Dicembrini I, Nreu B, et al. Glucagon-like peptide-1 receptor agonists and cardiovascular outcomes in patients with and without prior cardiovascular events: an updated meta-analysis and subgroup analysis of randomized controlled trials. Diab Obes Metab. 2020;22(2):203–211. DOI:10.1111/dom.13888
   PubMed Web of Science ®Google Scholar
• Flore G, Preti A, Carta MG, et al. Weight maintenance after dietary weight loss: systematic review and meta-analysis on the effectiveness of behavioural intensive intervention. Nutrients. 2022;14(6):1259. DOI:10.3390/nu14061259
   PubMed Web of Science ®Google Scholar
• Wadden TA, Berkowitz RI, Womble LG, et al. Randomized trial of lifestyle modification and pharmacotherapy for obesity. N Engl J Med. 2005;353(20):2111–2120. DOI:10.1056/NEJMoa050156
   PubMed Web of Science ®Google Scholar
• Allison DB, Bier DM, Locher JL. Measurement rigor is not a substitute for design rigor in causal inference: increased physical activity does cause (modest) weight loss. Int J Obes (Lond). 2022 Nov 28;47(1):3–4. Epub ahead of print. DOI:10.1038/s41366-022-01234-9
   PubMed Web of Science ®Google Scholar
• Pontzer H. Exercise is essential for health but a poor tool for weight loss: a reply to Allison and colleagues. Int J Obes (Lond). 2022 Dec 16;47(2):98–99. Epub ahead of print. DOI:10.1038/s41366-022-01248-3
   PubMed Web of Science ®Google Scholar
• He K, Guo Q, Zhang H, et al. Once-weekly semaglutide for obesity or overweight: a systematic review and meta-analysis. Diab Obes Metab. 2022;24(4):722–726. DOI:10.1111/dom.14612
   PubMed Web of Science ®Google Scholar
• Dawson JA, Kaiser KA, Affuso O, et al. Rigorous control conditions diminish treatment effects in weight loss-randomized controlled trials. Int J Obes (Lond). 2016;40(6):895–898. DOI:10.1038/ijo.2015.212
   PubMed Web of Science ®Google Scholar
• Adams TD, Pendleton RC, Strong MB, et al. Health outcomes of gastric bypass patients compared to nonsurgical, nonintervened severely obese. Obesity (Silver Spring). 2010;18(1):121–130. DOI:10.1038/oby.2009.178
   PubMed Web of Science ®Google Scholar
• Adams TD, Davidson LE, Litwin SE, et al. Health benefits of gastric bypass surgery after 6 years. JAMA. 2012;308(11):1122–1131. DOI:10.1001/2012.jama.11164
   PubMed Web of Science ®Google Scholar
• Salminen P, Helmiö M, Ovaska J, et al. Effect of laparoscopic sleeve gastrectomy vs laparoscopic Roux-en-Y gastric bypass on weight loss at 5 years among patients with morbid obesity: the SLEEVEPASS randomized clinical trial. JAMA. 2018;319(3):241–254. DOI:10.1001/jama.2017.20313
   PubMed Web of Science ®Google Scholar
• Heffron SP, Parikh A, Volodarskiy A, et al. Changes in lipid profile of obese patients following contemporary bariatric surgery: a meta-analysis. Am J Med. 2016;129(9):952–959. DOI:10.1016/j.amjmed.2016.02.004
   PubMed Web of Science ®Google Scholar
• MOUNJARO™ (tirzepatide) [package insert]. (IN)polis (IN): Lilly USA (LLC); 2022. Available from: https://uspl.lilly.com/mounjaro/mounjaro.html?s=pi
   Google Scholar
• Ma C, Avenell A, Bolland M, et al. Effects of weight loss interventions for adults who are obese on mortality, cardiovascular disease, and cancer: systematic review and meta-analysis. BMJ. 2017;359:j4849. DOI:10.1136/bmj.j4849
   PubMed Web of Science ®Google Scholar
• Goldberg RB, Orchard TJ, Crandall JP, et al. Effects of long-term metformin and lifestyle interventions on cardiovascular events in the Diabetes Prevention Program and its outcome study. Circulation. 2022;145(22):1632–1641.
   Google Scholar
• Bohula EA, Wiviott SD, McGuire DK, et al. Cardiovascular safety of lorcaserin in overweight or obese patients. N Engl J Med. 2018;379(12):1107–1117. DOI:10.1056/NEJMoa1808721
   PubMed Web of Science ®Google Scholar
• Nissen SE, Wolski KE, Prcela L, et al. Effect of naltrexone-bupropion on major adverse cardiovascular events in overweight and obese patients with cardiovascular risk factors: a randomized clinical trial. JAMA. 2016;315(10):990–1004. DOI:10.1001/jama.2016.1558
   PubMed Web of Science ®Google Scholar
• James WP, Caterson ID, Coutinho W, et al. Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects. N Engl J Med. 2010;363(10):905–917. DOI:10.1056/NEJMoa1003114
   PubMed Web of Science ®Google Scholar
• Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2016;375(4):311–322. DOI:10.1056/NEJMoa1603827
   PubMed Web of Science ®Google Scholar
• Davies MJ, Aronne LJ, Caterson ID, et al. Liraglutide and cardiovascular outcomes in adults with overweight or obesity: A post hoc analysis from SCALE randomized controlled trials. Diabetes Obes Metab. 2018;20(3):734–739. DOI:10.1111/dom.13125
   PubMed Web of Science ®Google Scholar
• Marso SP, Bain SC, Consoli A, et al. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. N Engl J Med. 2016;375(19):1834–1844. DOI:10.1056/NEJMoa1607141
   PubMed Web of Science ®Google Scholar
• Husain M, Birkenfeld AL, Donsmark M, et al. Oral semaglutide and cardiovascular outcomes in patients with type 2 diabetes. N Engl J Med. 2019;381(9):841–851. DOI:10.1056/NEJMoa1901118
   PubMed Web of Science ®Google Scholar
• Sattar N, McGuire DK, Pavo I, et al. Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis. Nat Med. 2022;28(3):591–598. DOI:10.1038/s41591-022-01707-4
   PubMed Web of Science ®Google Scholar
• Aminian A, Zajichek A, Arterburn DE, et al. Association of metabolic surgery with major adverse cardiovascular outcomes in patients with type 2 diabetes and obesity. JAMA. 2019;322(13):1271–1282. DOI:10.1001/jama.2019.14231
   PubMed Web of Science ®Google Scholar
• Lilly. News release - Lilly receives U.S. FDA fast track designation for tirzepatide for the treatment of adults with obesity, or overweight with weight-related comorbidities [Internet]. Indianapolis, IN: Lilly USA, LLC; 2022, Oct 6. [Cited 2023 Jan 6]. Available from: https://investor.lilly.com/news-releases/news-release-details/lilly-receives-us-fda-fast-track-designation-tirzepatide
   Google Scholar
• Lau DCW, Erichsen L, Francisco AM, et al. Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial. Lancet. 2021;398(10317):2160–2172. DOI:10.1016/S0140-6736(21)01751-7
   PubMed Web of Science ®Google Scholar
• Gadde KM, Allison DB. Long-acting amylin analogue for weight reduction. Lancet. 2021;398(10317):2132–2134.
   PubMed Web of Science ®Google Scholar
• Enebo LB, Berthelsen KK, Kankam M, et al. Safety, tolerability, pharmacokinetics, and pharmacodynamics of concomitant administration of multiple doses of cagrilintide with semaglutide 2·4 mg for weight management: a randomised, controlled, phase 1b trial. Lancet. 2021 May 8;397(10286):1736–1748.
   PubMed Web of Science ®Google Scholar
• Nordisk N. Company announcement. Novo Nordisk successfully completes phase 2 trial with CagriSema in people with type 2 diabetes [Internet]. Bagsværd, Denmark: Novo Nordisk A/S; 2022, Aug. 22 [Cited 2023 April 25]. Available from: https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=131155
   Google Scholar
• Nahra R, Wang T, Gadde KM et al. Effects of cotadutide on metabolic and hepatic parameters in adults with overweight or obesity and type 2 diabetes: a 54-week randomized phase 2b study. Diabetes Care. 2021;44(6):1433–1442.
   PubMed Web of Science ®Google Scholar
• Heymsfield SB, Coleman LA, Miller R, et al. Effect of bimagrumab vs placebo on body fat mass among adults with type 2 diabetes and obesity: a phase 2 randomized clinical trial. JAMA Netw Open. 2021;4(1):e2033457.
   PubMed Web of Science ®Google Scholar
• Perdomo CM, Cohen RV, Sumithran P, et al. Contemporary medical, device, and surgical therapies for obesity in adults. Lancet. 2023 Apr 1;401(10382):1116–1130.
   PubMed Web of Science ®Google Scholar
• Malhotra R, Ostbye T, Riley CM et al. Young adult weight trajectories through midlife by body mass category. Obesity (Silver Spring). 2013;21(9):1923–1934.
   PubMed Web of Science ®Google Scholar
• Gu H, Lu B, Gao Y, et al. Prognostic value of atherosclerosis progression for prediction of cardiovascular events in patients with nonobstructive coronary artery disease. Acad Radiol. 2021;28(7):980-987.
   Google Scholar